Kornimate/medical-research-clean huggingface dataset:
the use of a mitochondrial enhancement treatment in bipolar disorder

Conditions: Bipolar Depression

Summary: the primary objective of this 15-week clinical trial is to test the hypothesis that treatment with two proven mitochondrial enhancers, acetyl-l-carnitine (alcar) and α-lipoic acid (ala), has significantly greater efficacy than placebo as an augmentation treatment in bipolar depressed patients who display an incomplete response to conventional treatments.

the primary objective of this proposed clinical trial is to test the hypothesis that treatment with two proven mitochondrial enhancers, acetyl-l-carnitine (alcar) and α-lipoic acid (ala), has significantly greater efficacy than placebo as an augmentation treatment in bipolar depressed patients who display an incomplete response to conventional treatments. we propose to test this hypothesis by performing a 15-week placebo-controlled, double-blind, parallel group, flexible-dose study investigating the use of alcar and ala as an augmentation to treatment as usual in depressed bipolar patients. we will compare the efficacy of acetyl-l-carnitine (alcar) at doses of 1000-3000mg/day and alpha-lipoic acid (ala) at doses of 600-1800mg/day with placebo on symptom improvement in individuals diagnosed with bipolar disorder type i, current episode depressed. improvement will be assessed using the 21-item hamilton depression rating scale (ham-d), the montgomery asberg depression rating scale (madrs), the young mania rating scale (ymrs), and the clinical global impression-severity and improvement scales (cgi-s and cgi-i). furthermore, we hypothesize that improvement in depression symptoms following treatment with alcar and ala will be associated with increases in phosphocreatine (pcr), beta-nucleoside triphosphate (β-ntp), and intracellular ph in the anterior cingulate cortex (acc) both at week 1 and week 12 of treatment.

Eligibility criteria:
inclusion criteria: * male or female age 18-65 years. * meets dsm-iv criteria for bipolar disorder, type i with current episode depressed. * current score of greater than or equal to 18 on the 21-item hamilton depression rating scale at visits 1 and 2. * maintained on a stable treatment regimen with no changes in medication dosages for at least two weeks prior to study entry. exclusion criteria: * unwilling or unable to provide informed consent * score of greater than or equal to 12 on the young mania rating scale at visit 1 or 2. * current suicidal or homicidal ideation. * active psychotic symptoms. * lifetime history of schizophrenia or obsessive-compulsive disorder. * dsm-iv diagnosis of alcohol or substance dependence in the 3 months prior to screening. * clinically significant medical condition that would interfere with study participation. * history of hypersensitivity to aclcar or ala. * pregnant or lactating.

Keywords: bipolar disorder bipolar depression natural substances depression
changes of left atrial function and quality of life after transcatheter closure of left atrial appendage in patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: a total of 105 (af) patients with atrial fibrillation are scheduled to undergo surgery and will be divided into three groups. left atrial appendage occlusion ((laac)), radiofrequency ablation guided by three-dimensional mapping and laac combined with radiofrequency ablation were performed respectively (allocation ratio 1:1:1). all patients were examined by real-time three-dimensional and two-dimensional ultrasound before operation and 3, 6 and 12 months after operation, and the (la) function of left atrium was measured. all ultrasound data will be stored and the professional director of the ultrasound room will be invited to conduct quantitative analysis. ultrasonic examination indexes include: anterior and posterior diameter of left atrium, left atrial ejection fraction and so on. all patients underwent transesophageal echocardiography before and 3 months after operation. the results were interpreted by 2 experienced ultrasound doctors to measure the presence of left atrial thrombus, residual shunt and device-related thrombus. blood samples were taken to detect b-type natriuretic peptide before operation, 1 day, 3-6 months and 12 months after operation. all patients underwent 6-minute walking test and quality of life score before operation and 3, 6 and 12 months after operation. at the same time, the thickness of crest in all patients was measured during operation. this study will clarify the changes of left atrial function and quality of life in patients with atrial fibrillation after laac. in addition, this study also observed the effect of radiofrequency ablation combined with laac on left atrial function and evaluated whether one-stop surgery was superior to simple occlusion or ablation, and the above results were analyzed. the patients were followed up for an average of one year, and the changes of left atrial function, quality of life and embolic events were analyzed.


Eligibility criteria:
inclusion criteria: sustained af attack occurred in patients with a duration of more than one year, patients taking class i and class iii antiarrhythmic drugs could not prevent af, patients younger than 80 years old， cha2ds2-vasc score ≥2, not suitable for long-term oral anticoagulant drugs. exclusion criteria: patients with a history of atrial thrombosis or valvular heart disease (moderate or severe valve stenosis or severe valve regurgitation), patients undergoing prosthetic heart valve replacement, pregnant women, patients with previous liver and kidney diseases, malignant tumors or blood system diseases.

Keywords: atrial fibrillation left atrial appendage closure left atrial function quality of life
isolated bowman layer graft for reducing and stabilizing advanced keratoconus

Conditions: Advanced Keratoconus

Summary: to evaluate the efficacy of mid-stromal implantation of an isolated bowman layer graft, to reduce and stabilize ectasia in eyes with advanced keratoconus


Eligibility criteria:
inclusion criteria: •advanced keratoconus exclusion criteria: * further ophthalmic diseases * history of ocular surgery * pregnancy, brest feeding

Keywords: keratoconus bowman layer
evaluation of a 4mmx32g pen needle for injection of basal insulin doses above 40 units

Conditions: Diabetes Mellitus, Type 2

Summary: the primary purpose of this study is to demonstrate that the bd 4mm x 32g ultra-fine nano pen needle provides equivalent glycemic control to the bd 8mm x 31g ultra-fine short pen needle as measured by fructosamine (fru) among lantus®, levemir®, and/or nph users taking one or more single daily injections of greater than 40 units of insulin. glycemic control, injection pain, leakage, preference, comfort, and other parameters will be compared between the 4mm x 32g and the 8 mm x 31 g pen needle after three weeks of use of each device. sufficient numbers of subjects taking lantus® as their basal insulin will be enrolled so as to allow for pre-specified analysis of this subgroup.

this is an open-label, randomized two period crossover study. each subject's participation is expected to last about seven weeks and includes a brief enrolment period followed by two consecutive three week treatment periods (period 1 and period 2). in period 1, subjects will use the first assigned study pen needle (either the 4mm nano or the 8mm short) to self-administer daily all their pen-based diabetes medications. upon completion of period 1, subjects will switch to the alternate pen needle for period 2. the randomization schedule will determine the order of pen needle use. blood samples for determination of fasting blood glucose and serum fructosamine concentrations will be collected at baseline (visit 2) and the end of period 1 (visit 3) and period 2 (visit 4). blood samples will be analyzed by a central laboratory.

Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes mellitus * have been using a pen device for all diabetes or diabetes-related medications for at least one month prior to screening * use a pen device to self-administer greater than 40 units of lantus, levemir, and/or nph in one or more single injections. for split doses, at least one of the injections must deliver more than 40 units. * documented hemoglobin a1c (hba1c) from 5.5% to 9.5%, inclusive * self monitor blood glucose at once daily with a memory blood glucose meter, and willing do so at least twice per day for the duration of the study * on a stable diabetes regimen (insulin and non-insulin meds, diet and exercise) for at least 1 month prior to screening * able to read, write and follow instructions in english exclusion criteria: * current administration of insulin with a pump. * current use a syringe to inject insulin or any diabetes-related medication * participation in clinical study bddc-08-011 or dbc-10-squir05 * history of intravenous drug abuse. * current status or history of a medical condition that would contraindicate treatment with study products or other conditions which, in the opinion of the investigator, would place the subject at risk or potentially confound interpretation of the study results (i.e., recent history of ketoacidosis, hypoglycemic unawareness, etc). * pregnancy

Keywords: diabetes pen needle basal insulin long-acting insulin
can vibration stimulation of the foot sole activate leg muscles?

Conditions: Spinal Cord Injury

Summary: participants will be asked to complete three different tests (standing, stepping and assisted walking) and will experience three different experimental conditions during each test. the three conditions are types of vibratory plantar cutaneous stimulation, which include no vibratory stimulation, submaximal vibratory stimulation and supramaximal vibratory stimulation. in the first condition, participants will experience no stimulation applied to any part of the body. in the second condition, a submaximal vibratory stimulus will be delivered at 90% of the participant's threshold to the surface of the foot. in the third condition, a supramaximal vibratory stimulus will be delivered at three times the participant's threshold. the hypothesis is that this plantar stimulation (90% threshold and supramaximal) will elicit increased muscle activity during these tests. if the hypothesis is positive then this protocol will also be presented in incomplete spinal cord injuried participants.


Eligibility criteria:
inclusion criteria: * no spinal cord injury exclusion criteria: * any musculoskeletal or neurological disease that affects movement or balance
using intravenous heparin versus standard of care subcutaneous heparin to prevent clots after surgery

Conditions: Venous Thrombosis

Summary: this study plans to learn more about what is the best treatment to prevent blood clots in patients in intensive care units (icu's). the investigators know that patients who are in icu's have a higher than normal risk of getting blood clots in the veins of their arms or legs. this can be very dangerous as the clot may move into the lungs. to prevent this, the standard treatment is to give low dose heparin subcutaneously 3 times a day (usually 5000 units at each dose). in this study the investigators are randomizing patients to receive either standard of care or low dose intravenous heparin in a continuous infusion.

macro- and micro-thrombosis both contribute significantly to morbidity and mortality in the surgical intensive care unit. pulmonary embolism (pe) is a common and preventable cause of death in critically ill patients, with a mortality rate of up to 10%. up to 95% of cases of pe originate from deep venous thrombosis (dvt). there are multiple pharmacologic and non-pharmacologic methods of dvt prophylaxis.the current standard of care in thromboprophylaxis in the surgical intensive care unit (sicu) at the university of colorado hospital is low-dose subcutaneous heparin (sch). however, there is little evidence that this is the optimal prophylactic treatment. in fact, a database search of icd-9 diagnoses made in 2005 suggests that the incidence of dvt in sicu patients, the majority who receive subcutaneous heparin, is approximately 7%. surgical icu patients are at high risk of developing dvt during their hospital stay and likely need more aggressive anticoagulation. intravenous heparin, given at a low dose and titrated to a measurable endpoint ptt (partial thromboplastin time), may offer several benefits over the current standard of care, subcutaneous heparin. this method of treatment would offer more aggressive anticoagulation and allow dosage to be adjusted frequently based on each patient's changing coagulation status.

Eligibility criteria:
inclusion criteria: * a signed informed consent; * age between 18 and 80 years * the patient is admitted to the surgical intensive care unit at the university of colorado hospital exclusion criteria: * predicated sicu stay less than 5 days; * pregnancy; * breast feeding; * initial platelet count \< 30,000; * currently eligible for treatment of thromboembolism; * prior organ transplant; * cardiopulmonary bypass within previous 30 days; * advanced directive precluding participation; * already receiving pharmacologic agent for dvt prophylaxis; * prior diagnosis of heparin-induced thrombocytopenia; * heparin allergy

Keywords: venous thrombosis heparin pulmonary embolism icu
knee pain nurse led package of caretrial

Conditions: Osteoarthritis, Knee; Pain, Joint

Summary: 1. to develop a training package for nurse-led management of knee osteoarthritis (oa), incorporating information about oa and core non-pharmacologic and pharmacologic principles of management of oa as recommended in the national institute for clinical excellence and health (nice) guidelines for management of oa 2. to evaluate fidelity of delivery of individual components of this complex package of care for knee pain 3. to assess the acceptability of the intervention by exploring participant satisfaction with nurse-led complex package of care of knee pain. 4. to explore and resolve possible challenges to delivery of individual components within a complex package 5. to examine the feasibility of a definitive cohort randomised controlled trial of nurse-led care versus usual care of knee pain in terms of recruitment rate, drop-out rate, reasons for dropping out and completeness of outcome data 6. to explore whether such a trial should provide analgesia before non-pharmacologic interventions or vice versa


Eligibility criteria:
inclusion criteria: * knee pain on most days of the previous month * at least moderate pain on two of the five womac knee pain domains in the most painful knee * knee pain present for longer than 3 months exclusion criteria:• house-bound or care home resident * dementia * dialysis * on home oxygen * serious mental illness * inability to communicate in english * unable to give consent * terminal cancer * known diagnosis of autoimmune rheumatic diseases or psoriasis * knee or hip replacement, or on waiting list for knee or hip replacement * asthma or copd requiring regular daily oral corticosteroids * unstable angina or heart failure * known peripheral vascular disease * pregnant
the essential tremor (et) and parkinson disease (pd) tremor acute stimulation study

Conditions: Essential Tremor; Parkinson Disease

Summary: the current study is designed to test the hypothesis that targeted electrical stimulation will result in upper limb tremor reduction in et and pd patients.

this study will evaluate the effect of rainbow medical's stimulation procedure methodology that will be applied temporarily to patients suffering of tremor. this will be evaluated by assessment of reduction of tremor using accelerometer measurements, patient tremor evaluation diary, tremor rating scale, and the unified parkinson's disease rating scale (uprds) part iii.in addition,tasks for patient with tremor will be conducted before during and after the treatment. the above measurements will provide data on the stimulation procedure effect as compared to baseline.

Eligibility criteria:
inclusion criteria: * able to sign written informed consent in hebrew. * patient agrees to attend all treatment procedures and follow-up evaluations and is willing and able to comply with all study requirements. * patient with a clinical diagnosis of idiopathic pd, or et for more than 3 years. * significant tremor for at least one upper limb causing distress or disability. * patient should be stable on anti-parkinson's disease or anti-tremor medication for at least one month prior to study enrollment. exclusion criteria: * previous participation in another study with any investigational drug or device within the past 90 days. * any active implant (cardiac or other). * current pregnancy or attempting to get pregnant (female patient). * patient has any major illness or medical condition that in the opinion of the physician would interfere with participation in the study. * patient with other significant neurological or psychiatric disease other than parkinson disease or essential tremor. * patient has any other condition expect for pd and et that induce tremor. * patient is treated with drug that may induce tremor. * patient abuses drugs or alcohol. * any previous thalamotomy, pallidotomy or patient who has undergone a dbs procedure. * any anticipated need for surgery during the study. * any malignancy in the past 2 years. * patient has confirmation of diagnosis of a terminal illness associated with survival \<12 months.

Keywords: essential tremor parkinson disease electrical stimulation tremor
a study of ro4917838 (bitopertin) in patients with persistent, predominant negative symptoms of schizophrenia (wn25309)

Conditions: Schizophrenia

Summary: this multi-center, randomized, double blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of ro4917838 (bitopertin) in patients with persistent, predominant negative symptoms of schizophrenia. patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of ro4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.


Eligibility criteria:
inclusion criteria: * adult patients, aged 18 years and above * diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype * predominant negative symptoms * with the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics) exclusion criteria: * evidence that patient has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder) * body mass index (bmi) of \ 40 kg/m2 * depressive symptoms, defined as a score of 9 or greater on the calgary depression rating scale for schizophrenia (cdss) * a severity score of 3 or greater on the parkinsonism item of the esrs-a (clinical global impression, parkinsonism)
binge eating self-help treatment for university students

Conditions: Obesity; Binge Eating Disorder

Summary: best4us compares the effectiveness of two forms of self-help interventions that target college students, ages 18 years to 22 years, who report binge eating. the overall question is whether one or the other format will prevent excess weight gain and lead to differences in eating behaviors. the two formats are (1) "pure self-help" (receipt of a self-help program via book form or online texts) and (2) a combination of the self-help program and guidance provided by a trained peer coach over the course of 8 weekly sessions.


Eligibility criteria:
inclusion criteria: * binge eating episodes at least once per week in the past 28 days * 18 to 22 years old * full-time student at wesleyan university (middletown, ct, usa) or manchester community college (manchester, ct, usa) exclusion criteria: * purging more than once per week in the past three months * bmi less than 18 or greater than/equal to 40 * currently pregnant * severe depressive symptoms or suicidality

Keywords: obesity weight gain prevention eating disorder binge eating
effect of paricalcitol (zemplar) on endothelial function and inflammation in type 2 diabetes and chronic kidney disease

Conditions: Type 2 Diabetes; Chronic Kidney Disease

Summary: the purpose of this research study is to study the effects of paricalcitol on endothelial function and inflammation, cardiovascular risk factors which are associated with patient populations that have type 2 diabetes and stage 3 and 4 chronic kidney disease (ckd). hypothesis 1: the state of ckd is associated with oxidative stress and inflammation and impaired post ischemic endothelium dependent flow mediated vasodilation which may contribute to atherogenesis. hypothesis 2: the administration of paracalcitol to patients with ckd will suppress oxidative stress and inflammation and improve endothelial function and thus contribute to an anti-atherogenic action.


Eligibility criteria:
inclusion criteria: 1. patients with type 2 diabetes and ckd 2. age 18 - 70 years 3. stable anti-hypertensive and lipid lowering therapy for at least 2 months. all patients should be on an acei or arb unless contraindicated because of side effects (standard of care). no changes in lipid lowering therapy during the 3 months of this study. blood pressure doses may be changed but new therapy with ace inhibitors will not be allowed. exclusion criteria: 1. severe co morbid conditions - e.g. cancer, etc. 2. congestive heart failure. 3. inability to give informed consent or attend study related visits. 4. have a history of abnormally high vitamin d or calcium levels in the bloodstream. 5. unwilling or unable to complete screening or data collection procedures. 6. have a known allergy to the study drug. 7. pregnant or breast feeding 8. plasma calcium \>9 mg/dl 9. patients should discontinue any calcium supplementation prior to entry into the study. 10. other vitamin d analogs (eg sensipar) and vitamin d preparations are contraindicated

Keywords: stage 3 chronic kidney disease (ckd) stage 4 chronic kidney disease (ckd) ckd
bevacizumab versus micropulse in central serous chorioretinopathy (csc)

Conditions: Central Serous Chorioretinopathy

Summary: the purpose of this study is to evaluate the clinical efficacy of an initial subthreshold retinal micropulselasercoagulation versus a single intravitreal 1.5mg bevacizumab injection in central serous choriretinopathy, as the micropulse will selectively treat the damaged rpe to induce reproliferation of healthy rpe cells, whereas the intravitreal injection should non-selectively stop the rpe leakage.

to evaluate the clinical efficacy of an initial subthreshold retinal micropulselasercoagulation in twelve eyey per group versus a single intravitreal 1.5mg bevacizumab injection in central serous choriretinopathy, as the micropulse will selectively treat the damaged rpe to induce reproliferation of healthy rpe cells. bcva in edtrs score, oct, and leakage in fla, static perimetry of both groups will be correlated to a control group without treatment over 10 months.

Eligibility criteria:
inclusion criteria: * csc of \>4 months duration exclusion criteria: * history of macular or chorioretinal inflammation * lens / corneal opacities

Keywords: micropulselaserphotocoagulation bevacizumab csc